BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS? VASCULAR SD

    MDR report key: 3971309 · Received July 31, 2014

    Report

    Report Number
    2134265-2014-04460
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    March 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR.: THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT MOVED DISTAL OF THE PROXIMAL MARKERBAND. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE STENT MOVEMENT OR THE REPORTED DIFFICULTY CROSSING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS APPROVED ON (B)(4) 2014. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE RENAL ARTERY. A 6.0MMX18MMX150CM EXPRESS¿ VASCULAR SD STENT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A STENT MOVED ON BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446881 EXPRESS? VASCULAR SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937918618150 16485952

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR